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This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients will be enrolled and randomly assigned to two surgical method groups: RIMA-SVG Group (150 patients): SVGs are connected to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The aorta is clamped, and SVGs are connected to the ascending aorta (Ao).All patients will undergo CABG on a beating heart with sequential vein grafts to bypass at least two or more coronary vessels. The primary outcome is 1-year graft patency. The secondary outcomes include neurological complications, mortality, major adverse cardiovascular events (MACE), and surgical site infection event.
This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients undergoing CABG on a beating heart will be randomized into two surgical technique groups: RIMA-SV Group (150 patients): SVGs are anastomosed to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The ascending aorta is clamped, and SVGs are anastomosed to the aorta. All patients will undergo CABG via median sternotomy, and the left internal mammary artery (LIMA) will be used to bypass the left anterior descending artery (LAD). SVGs will be sequentially grafted to the circumflex artery, diagonal branch, and right coronary artery. The primary outcome is 1-year graft patency, assessed by coronary CT angiography and classified using the FitzGibbon grading system. Secondary outcomes include all-cause mortality, major adverse cardiovascular events (MACE), neurological complications, and surgical site infection event. Patients will be followed at 12 months for clinical evaluations and imaging assessments. Inclusion criteria include patients aged 18 to 80 years undergoing planned CABG with at least two sequential saphenous vein grafts and who are able to provide written informed consent. Exclusion criteria include additional cardiac surgeries, severe subclavian artery stenosis, unsuitable SVGs (e.g. bilateral varicosities), history of intracranial hemorrhage, active bleeding, malignancy, or emergency surgery. Randomization will be computer-generated, and all aspects of the study will remain blinded to ensure unbiased assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIMA-SVG Group | Experimental | Saphenous vein grafts (SVGs) will be connected to the right internal mammary artery (RIMA). |
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| Ao-SVG Group | Active Comparator | SVGs will be connected directly to the ascending aorta. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIMA-SVG | Procedure | Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-Year Graft Patency | The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography | 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complications | Incidence of Perioperative complications related to CABG, including myocardial infarction, arrhythmias and other major adverse events. | 2 weeks post-surgery |
| Neurological Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kexiang liu, Ph.D. | Second Hospital of Jilin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41022447 | Derived | Wei R, Huang M, Jiang N, Zhang R, He T, Zhu C, Wang W, Piao H, Yu S, Zhu Z, Wang T, Liu K. RIMA-SVG versus Ao-SVG in coronary artery bypass grafting: protocol for a prospective, randomised, double-blind, non-inferiority and single-centre trial. BMJ Open. 2025 Sep 28;15(9):e104578. doi: 10.1136/bmjopen-2025-104578. |
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De-identified individual participant data (IPD) underlying the primary and secondary outcomes of the study-including baseline characteristics, graft patency results, perioperative complications, and 12-month clinical outcomes-will be made available upon reasonable request. Data will be shared with qualified researchers following study completion and publication, subject to approval by the trial steering committee and in accordance with ethical and data protection guidelines.
Data will be shared via request from the corresponding author starting 6 months after study completion and publication.
Access to the de-identified individual participant data will be granted to qualified researchers whose proposed use of the data has been reviewed and approved by the trial's principal investigator and data access committee. Applicants must submit a detailed research proposal outlining the scientific rationale, intended analyses, and data protection measures. A data use agreement must be signed prior to data release to ensure compliance with ethical and legal standards.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Participants are randomly assigned to two groups based on surgical technique (RIMA-SVG vs. Ao-SVG)
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The surgical team is unblinded during the procedure, but patients and investigators remain blinded throughout the study.
| Ao-SVG | Procedure | The ascending aorta is clamped, and SVGs are anastomosed to the aorta. |
|
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Incidence of neurological complications, including stroke within 1 year after CABG.
| 1 year post-surgery |
| All-Cause Mortality | Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, Incidence of death from any cause within 1 year after CABG. | 1 year post-surgery |
| Major Adverse Cardiovascular Events (MACE) | Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, and target vessel revascularization, within 1 year after CABG.after CABG. | 1 year post-surgery |
| Surgical site infection event | Incidence of surgical site infection event during hospitalization and within 1 year | 1 year post-surgery |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |